Dental tray spacer

ABSTRACT

A convenient dental tray spacer for use in forming a thin reservoir space between teeth and a dental tray, during tray fabrication. Shim ( 10 ) segments are connected by small links ( 12 ) to form a spacer ( 16 ). The lengths of the links are readily variable. Retention to the teeth is provided by adhesive on rear adhesive surfaces ( 22 ). Alternatively, an elastic loop ( 24 ) can retain a spacer ( 16 ′). Spacer ( 16 ), or spacer ( 16 ′), remain on the teeth while the dental tray is formed, and then is pulled free from inside the formed dental trays.

BACKGROUND—FIELD OF THE INVENTION

This invention relates to medicine and dentistry, specifically to animproved method and apparatus for fabricating custom dental treatmenttrays for applying treatment agents to the teeth and/or gingiva.

BACKGROUND—DESCRIPTION OF PRIOR ART

Custom dental treatment trays are used to hold tooth whitening orbleaching gels, fluoride, topical anesthetics, antibiotics,antihistamines, medications, and other such treatment agents, closelyagainst the surfaces of the teeth and/or gingiva for extended times.Dental trays typically are made by tightly suctioning softenedelastomeric sheets of stock tray material onto plaster models of thepatient's dental arches. Excess tray material is then trimmed away toachieve the desired tray shape. Dental trays are most effective whenfabricated with slight spacing created between the surfaces of the teethand the tray material. This provides room, or a reservoir, for thetreatment agents. Without a reservoir space, the tray material itselftightly contacts the broad surfaces of the teeth, and the treatmentagents tend to be displaced. When this occurs, the beneficial effects ofthe treatment agents are reduced, and the treatment time, the amount oftreatment agents required, and irritational side effects are increased.

There is a problem with creating the reservoir space under the dentaltrays, however, and that is the considerable time it requires for dentalpersonnel. Cost is also a factor for some techniques.

The most widely used dental tray spacing technique involves manuallypainting a liquid spacer material, such as thick fingernail polish, ontothe appropriate areas of the patient's teeth, or models of their teeth,prior to forming the trays. The depth of the paint itself forms the trayspace. Typically, only one coat is painted on, although this forms arelatively thin space, and it must be allowed to dry before the dentaltray may be fabricated. A border area around the circumference of thetooth remains unspaced, in order to seal off the reservoir area fromsaliva, and to retain the treatment agent. The first disadvantage tothis technique is that several minutes are required to apply one coat ofspacer paint, plus about twenty minutes for drying. The seconddisadvantage is that multiple coats are needed to achieve an idealthickness for the reservoir space. Since that would require excessivetime, a minimally adequate reservoir depth from just one coat is usuallytolerated as better than none. A third disadvantage is that the thinspacing is not readily apparent when inspecting the tray visually. Thusthe dentist or patient, who is to purchase the spaced dental tray, mustrely on the word of the maker that is was actually spaced. This is adisincentive for laboratory and dental personnel to accept theinconvenience and cost of properly spacing the dental trays.

A similar technique involves manually painting viscous light-curedspacing resin over the teeth surfaces, instead of fingernail polish.Again, it is not applied to the border area, so that a seal may becreated for retaining the treatment agent over the treatment surface,and to seal out saliva. It creates a more ideal thickness of reservoirspace with a single coat. However, it still has the disadvantage ofrequiting requiring several minutes to paint on the teeth. Then, theresin is hardened with two minutes exposure to a special curing lamp.Another disadvantage is the considerable cost of the special curing lampapparatus. To avoid that expense, many dentists cure with their existingintraoral curing lamps instead. Unfortunately, these require a twenty toforty second exposure time per tooth, which more than doubles the timerequired to cure the resin spacing medium, and these lamps have higheroperational costs. The light-cured resin itself is also costly.

Another technique involves molding clay-like material onto the surfacesof the teeth. Again, the border seal area is left unspaced. Thistechnique requires some sculpting skill, and still greater applicationtime. It is not commonly used.

Another technique, described as the primary embodiment in U.S. Pat. No.5,356,291 to Darnell (1994), involves covering the entire inner surfaceof the tray with a sheet of open or closed cell foam, or a sheet offibrous absorbent material. This does not create an effective borderseal, so it is somewhat ineffective in retaining and restricting thetreatment agent to the area immediately over the teeth. Instead, thetreatment agent is permitted to dissipate in concentration andeffectiveness over the treatment surfaces, while saliva increasinglysoaks into its place. At the same time, the treatment agent may flow outover the gingiva or root areas, where it may cause irritation. This isespecially true for tooth bleaching gels. A second disadvantage is thatthe foam or fiber quickly accumulates heavy bacteria plaque and debris,and begins to look and smell badly. Repeated cleaning the foam or fibertends to destroy it, as it is somewhat fragile. The foam or fiber alsodeteriorates and oxidizes more quickly than the dental tray materialthat backs it.

A secondary embodiment of Darnell (1994) utilizes foam or fiber materialsegments to act as treatment agent reservoirs between the tray andindividual teeth. The disadvantage is that the construction is tedious,and the resulting tray is difficult to clean. Darnell does not teachremovable shims for dental tray spacing.

A tertiary embodiment of Darnell (1994) involves creating the spacebetween the dental tray and the teeth by abrading or sandblasting awaysome of the inner surface dental tray material from the formed dentaltray. The disadvantages of this technique are that costly sandblastingapparatus is required, that skillful, highly attentive workmanship isrequired to accurately cut away dental tray material, and that thedental tray material is somewhat weakened over the indentation/reservoirsite. Thicker, less comfortable, tray material is required, than fortechniques which do not thin the tray.

Another technique, reported in U.S. Pat. No. 5,326,685 to Gaglio et al.(1994), utilizes an impervious flexible backing material over anopen-cell foam, to create a reservoir for treatment agents. Anadditional reservoir is formed by sealing the borders of the foam to thebacking material, thus creating a space between them. Disadvantages ofthis technique include complex fabrication, additional steps beingrequired to load treatment agents into the reservoir spaces, theinability to seal the treatment surfaces from saliva, the inability toseal or restrict the treatment agents to the treatment surfaces, anddifficulty cleaning the open cell foam.

Millions of dental trays are currently in use, most for bleaching teeth.Many are fabricated without spacing built in at all, because of the costand inconvenience to the dental personnel to make spaced trays. Butunspaced dental trays waste the time and money of patients who attemptto utilize them. The resilient dental tray material squeezes thetreatment agents away from the desired location, reducing theeffectiveness and efficiency. Bleaching sessions typically last severalhours of time, and the bleaching agents are costly. The process isfurther undetermined because the displaced bleach increasingly contacts,and may irritate, the gingiva and root areas of the teeth.

A dental tray spacer has not been produced to date because it is notobvious how to connect shim segments for convenient mounting on the widevariety of dental arches, with their differences in distances betweentooth centers, tooth sizes, shapes, misalignments, gaps and rotations.

OBJECTS AND ADVANTAGES

Accordingly, several objects and advantages of the present inventionare:

(a) to provide an improved method for forming reservoir spaces underdental trays, for treating teeth with treatment agents, which producesresults which are superior to the results heretofore known to the art;

(b) to provide a spacer comprising multiple connected shims, each ofwhich mount on individual teeth, such that several teeth of a dentalarch of teeth may be quickly shimmed with a single spacer;

(c) to provide a spacer which is shaped to form adequate reservoirspaces under dental trays, as the trays are formed, wherein such spacescan readily receive and hold treatment agents;

(d) to provide a spacer shaped to substantially cover surfaces of teeth,leaving a circumferential area of the tooth surface uncovered, andunspaced, such that the formed tray rests directly against thecircumference of the tooth, thus enclosing a central, spaced, reservoirarea which can retain treatment agents, while restricting oral fluidsfrom treated tooth surfaces;

(e) to provide a spacer which is somewhat deformable, to compensate forvariations in the size, shape and spacing between individual teeth of adental arch;

(f) to provide a spacer comprising multiple shims connected by links ofvariable effective length, such that the distance between individualshims is similarly variable;

(g) to provide a spacer whose tray spacing will be visually apparent, toassure the purchaser of the formed dental tray;

(h) to provide a spacer that creates accessible, cleanable reservoirspaces in formed dental trays, such that bacterial plaque and debris arenot readily harbored;

(i) to provide a spacer that creates reservoir surfaces in the formeddental trays that do not deteriorate quickly, such as by tearing oroxidation of materials.

Further objects are to provide a spacer that requires minimal time andskill to mount to relevant surfaces of the teeth or dental models, andis economical to use. The foregoing has outlined some of the morepertinent objects of the present invention. These objects should beconstrued as being merely illustrative of some of the more prominentfeatures and applications of the invention. Many other beneficialresults can be obtained by applying the disclosed invention in adifferent manner or modifying the invention within the scope of theinvention. Accordingly further objects, advantages and understanding ofthe invention may be had by referring to the summary of the invention,and the detailed description, in addition to the scope of the inventiondefined by the claims taken in conjunction with the accompanyingdrawings.

DRAWING FIGURES

In the drawings, closely related figures have the same number, butdifferent alphabetic suffixes.

FIG. 1 is an elevational view of the spacer on a backing strip.

FIG. 2 is a perspective view of the spacer in place on a dental archmodel.

FIG. 3 is an elevational view of the spacer worm variation, on anadhesive backing strip.

FIG. 4 is a perspective view of the spacer worm variation, and the softtissue spacer variation, in place on a dental arch model.

FIGS. 5A to 5F show selected cross-sectional embodiments of spacershims.

FIG. 6 shows a perspective view of a spacer retained by an elastic loop.

REFERENCE NUMERALS IN DRAWINGS 10 SHIM

12 link

14 backing

16′ spacer

20 spacer worm

22 adhesive surface

26 loop anchor

10′ shim

12′ elastic link

16 spacer

18 model

21 soft tissue spacer

24 loop

SUMMARY

A Dental Tray Spacer is a linked strand of multiple tooth shims formounting on the surfaces of teeth, or replicas of teeth. The shims causea reservoir space to form between dental trays and the oral structures,during the fabrication of the dental trays. It should be appreciated bythose skilled in the art that the conception and specifics disclosed maybe readily utilized as a basis for modifying or designing otherstructures for carrying out the same purposes of the present invention.It should also be realized by those skilled in the art that suchequivalent constructions do not depart form the spirit and scope of theinvention as set forth in the appended claims.

DESCRIPTION OF INVENTION—FIGS. 1 TO 6

FIG. 1 shows an elevational view of a preferred embodiment of my dentaltray spacer. Individual spacer tooth shim elements, shims 10, areprovided in a flat, connected strip, spacer 16. Shims 10 are connectedto form spacer 16 by links 12. For spacer 16, the first shim 10 isconnected to the first link 12. The first link 12 is connected to thesecond shim 10. The second shim 10 is connected to the third link 12,and so on, through the final shim 10. The number of shims 10 shown inspacer 16 is typical. However, there could be more, or fewer, shims 10.Spacer 16 is supplied mounted on a backing sheet, backing 14.

The circumference form, or circumferential shape, of each shim 10approximates the circumferential shape of the corresponding, respective,tooth upon which it is to be mounted. For example, the shim 10 which isto mounted on the surface of the canine tooth has a circumferentialshape somewhat resembling that of a canine tooth. The sequential orderof the variously shaped shims 10 along spacer 16, corresponds with thetypical sequence of teeth. Such sequential grouping of spacers 10 bysize and shape makes spacers 16 convenient. However, shims 10 can have auniversal circumferential shape, such as an ovoid shape. A selection ofsizes enhances the likelihood of adequate coverage of the toothsurfaces. The circumferences of shims 10 are substantially in the planeof the spacer 16 strip.

Generally, the shim 10 circumference will be just slightly smaller thanthe circumference of the tooth upon which it is to be applied. Thus, asmall circumferential area of the tooth surface bordering shim 10remains uncovered, and unspaced. A dental tray formed over such unspacedcircumferential tooth surfaces would rest directly against thecircumferential surfaces of the tooth. This creates a sealing effect,enclosing a central, spaced, reservoir area which can retain treatmentagents. Similarly, the movement of oral fluids into the circumferentialarea is somewhat restricted. If unspaced border areas are small, thentreatment agents from the spaced dental tray reservoir, will feed to theborder adequately enough to treat the border area.

The material from which shims 10 are fabricated is pliable anddeformable. Pliability of shims 10 facilitates conforming to the surfacecontours of the respective mounting teeth. It is preferable that thematerial also be sufficiently deformable to permit slightly altering thedimensions by pushing the material over the tooth surface. The materialmay be adequately deformable at room temperature, or its pliability maybe increased by heating, or by treating with a solvent. A number ofpliable materials are effective. The material cuts readily with scissorsor blades to facilitate trimming down the shape where indicated.

Links 12 are connected between shims 10 to facilitate mounting on theteeth. It is preferred that links 12 are comprised of tough, flexiblematerial, continuous with the material of shims 10. However, links 12may be manufactured from different material than that used for shims 10.Links 12 are of sufficient strength so as to resist inadvertent ruptureduring routine mounting procedures.

The length of links 12 is sufficient to permit mounting any two linkedshims 10 on adjacent, ideally aligned, teeth. Ideally aligned teethcontact one another in the interproximal areas, and the plane planes ofthe facial surfaces of the teeth are substantially tangential to thecurvature of the dental arch. The length of links 12 required forconnected mounting of shims 10 on ideally aligned teeth, is a minimallength.

In the preferred embodiment, the length of links 12 is furthersufficient for mounting connected shims 10 on substantially misalignedteeth. Misaligned teeth have gaps, tipping, and rotations, whichincrease the minimal link 12 length required for mounting shims 10. Assuch, links 12 are of greater length than required for mounting onideally aligned teeth.

When mounting spacer 16 on substantially aligned teeth, there remains anunutilized portion of the length of links 12. To prevent inadvertententanglement, such unutilized length portions of links 12 are weaklyconnected adjacent to some spacer 16 structure by a separable connectionmeans. The separable connection positions such unutilized lengths oflinks 12 out of the way of the operator, in reserve. The separableconnection is of sufficient strength so as to resist inadvertentseparation during routine mounting procedures.

The separate connection is sufficiently weak such that purposefulseparation of shims 10 can separate the separable connection withoutrupture of other spacer 16 structures, such as when mounting links 12 onmisaligned teeth. When the separable connection is separated, theutilized length of links 12 is effectively increased. The unutilizedlength of links 12 can be considered to be effectively decreased,proportionally. As such, adjacent shims 10 thereby remain connectedwhile mounted on teeth with greater, or increased, separation distance.The effective length of links 12 can therefore be considered to bevariable.

In the preferred embodiment, the separable connection is a thin membraneof shim 10 material. The thin membrane is weak enough to be purposelytorn, but is sufficiently strong to remain intact during routinemounting of spacer 16.

In the preferred embodiment, the separable connection connects theunutilized length portions of links 12 to shim 10. Each link 12 isconfigured in a bow which point toward the incisal edges of the teeth.However, links 12 may be configured in a bow which point toward thegingival border of the teeth. The unutilized length portions of links 12are oriented somewhat incisally to gingivally, along the lateral borderof shims 10. The utilizable length portion of the link 12 has asubstantial mesial to distal orientation, and is located at the apex ofthe link 12 bow.

Although they are of narrow width relative to shims 10, links 12 havedistinctive cross-sectional shapes to minimize entrapment in a formeddental tray. Preferred shapes would be those with carved surfaces, suchas cylindrical or ovoid. However, when the rear surfaces of the linksare angular or flattened, it is preferable that they exhibit adhesiveproperties. Thus, they could be pressed into the embrasure crevice, andadhered to the teeth, out of the way of a forming dental tray.

FIG. 2 shows a perspective view of spacer 16 mounted on a dental archmodel, model 18, ready for dental tray fabrication. However, forintraoral dental tray fabrication techniques, spacer 16 would be mountedon a patient's actual teeth, intraorally. Uncovered circumferentialareas are apparent about shims 10.

FIG. 3 shows a perspective view of an alternative dental tray spacer, aspacer worm 20, as supplied on backing 14. Spacer worm 20 is acontinuous spacer strip, whose height is preformed in sizes thatapproximate the heights of teeth, whose thickness is preformed to createan adequate reservoir space, and whose spacer portions over teethsurfaces are connected continuously by broad linking areas between theteeth, with both spacer areas and link areas having the same height.Spacer worm 20 and backing 14 may be supplied wound on a spool ofindefinite length, to be cut to the appropriate length.

FIG. 4 shows a perspective view of spacer worm 20 cut to length and inplace on dental arch model 18, ready for dental tray fabrication. Theelement of spacer worm 20 must be more pliable and deformable thanspacer 16, to facilitate mounting on the teeth. It is sufficientlypliable to press into the embrasure crevice between the teeth, despitethe breadth of the linking areas. It is sufficiently deformable topermit altering the height dimension, by pushing the element on thetooth surface, such as in areas adjacent to the gingiva. It may beadequately deformable at room temperature, or the pliability may beincreased by heating, or by treating with a solvent.

FIG. 4 also shows a perspective view of soft tissue spacer 21 mounted ona selected site on a model 18. Soft tissue spacer 21 may be mountedanywhere on the gingiva, the gingival margin adjacent to the teeth, orthe oral mucosal tissue, that the dental tray can extend. Soft tissuespacer 21 will typically be provided in symmetrical shapes and sizes.Soft tissue spacer 21 effectively builds out the surface of the mountingsite so that a reservoir space can be created under the forming dentaltray. Optional soft tissue spacers 21 with an outer surfacecolor-transfer dye or decal can be convenient for clearly marking thereservoir location in the formed dental tray.

FIGS. 5A to 5F show selected cross-sectional embodiments of shims 10.Cross-sectional shapes shown are 5A lens-shaped, 5B uniform thickness,5C teardrop, 5D corrugated, 5E concave, and 5F convex. The teardrop,concave, and convex shapes especially facilitate the manual extension ofspacer coverage where necessary, such as for longer teeth, or to extenddown the root toward the gingiva of teeth where the gums have receded,or for lapping over an incisal edge of a tooth. It is preferred that thedepth, or thickness, of any cross-section is less than 1 mm. However, athickness of 1 mm or greater is also effective. Where possible, spacer16 edges are tapered to a sharp acute angle, such that they will adhereflush to the teeth, and minimize surface undercuts. This will minimizelocking into the dental tray during its fabrication.

Adhesive Surface 22 is the surface of spacer 16 that is to conformablymount onto the teeth. Adhesive Surface 22 is sufficiently pliable toconform closely to the curved, irregular surfaces of teeth or tissue. Itis preferred that adhesive surface 22 be supplied exhibiting sufficientadhesive properties to retain spacer 16 on irregular tooth surfacesduring the fabrication of the dental tray. However, spacer 16 may besupplied from the manufacturer without adhesive surface 22 exhibitingadhesive properties. As such, the user would apply an adhesive, such asa liquid glue, prior to mounting on model 18.

The adhesive properties of adhesive surface 22 are temporarily andreversibly inhibited, such as with backing 14, or other means ofadhesive inhibition. Such inhibition of adhesive surface 22 is reversedprior to mounting on model 18 by removing backing 14. However,inhibition of adhesive surface 22 can be reversed by removing some otherprotective coating, by heating, by wetting with a solvent, and so on.

FIG. 6 shows a perspective view of a spacer 16′ retained by an elasticloop, loop 24. It is preferred that spacer 16′ is not simultaneouslyretained by loop 24 and adhesion. However, simultaneous retention withadhesion is effective. Loop 24 connects the rightmost and leftmostportions or shims 10′, behind spacer 16′. Loop 24 retained spacer 16′ issubstantially configured as a closed loop, rather than a flat strip. Thecircumferences of shim 10′ are substantially perpendicular to the planeof such a spacer 16′ loop. Loop 24 is shown stretched between theposteriormost teeth on opposing sides of the dental arch of model 18.Stretched thus, loop 24 will typically be suspended a distance above theposterior palate. To prevent suspended loop 24 from becoming locked intoa forming dental tray, it is drawn down to the palate by hooking itsmidpoint on an anchor, loop anchor 26. However, other anchoring devicesare effective, or the anchor can be eliminated. Loop anchor 26 is heldin its position simply by the weight of model 18.

When spacer 16′ is retained by loop 24, it is preferred that the linksbe comprised of elastic material, forming elastic links 12′. Elasticlinks 12′ may generally be shorter than links 12, and do not necessarilybow between teeth. The lengths of unstretched elastic links 12′approximate the distance between borders of shims 10′ mounted on ideallyaligned teeth. Elastic Links 12′ stretch to accommodate correctpositioning of shims 10′ during mounting on model 18. As such, elasticlinks 12′ have a variable length. For misaligned teeth, the variablelength is utilized by stretching links 12′ across the increased distancebetween the teeth, to position adjacent connected shims 10′.

From the description above, a number of advantages of my dental trayspacer become evident:

(a) Preformed spacers minimize the steps required to form adequate andeffective reservoir spaces in formed dental trays.

(b) The spacer can be deformed to compensate for variations in the size,shape and spacing between individual teeth of a dental arch, tofacilitate mounting.

(c) The spacer is comprised of multiple shims connected by links withvariable effective lengths, such that the distance between individualshims is variable, and may be increased.

(d) Treatment agents are restricted to the reservoir spaces by borderseals around the circumferences of the treatment surfaces, and oralfluids are likewise restrained from the treatment surfaces.

(e) Required time and cost is minimized in applying dental tray spacers.

(f) Persons less skilled in dental procedures can apply spacers.

(g) It is visually apparent that the completed dental trays havetreatment agent reservoir spaces.

(h) Dental trays formed utilizing the spacers are durable and readilycleanable.

Operation of Invention—FIGS. 1 to 6

Model 18 is free of artifacts, clean and dried. A spacer 16 is selected,whose shims 10 are just slightly smaller than the teeth of model 18, tofacilitate formation of a circumferential seal. Spacer 16 is alsoselected for the most effective cross-sectional shape, shown in FIG. 5,as each shape has unique characteristics for adhering to the teeth. Inaddition, each shape imparts a unique shape to the subsequently formedreservoir.

Spacer 16 is removed from adhesive backing strip 14, shown in FIG. 1. Ifspacer 16 is judged to be less pliable than is necessary for mounting,then the pliability may be increased, by exposure to heat, solvent, orsuch. Spacer 16 is oriented over the teeth of model 18. The first shim10 is centered over the respective tooth of corresponding shape andposition. Shim 10 is mounted by pressing onto the tooth surface, suchthat shim 10 is conformed to the tooth surface contours. Adhesion ofshim 10 to the tooth is thus maximized. If the second respective toothis aligned with the first tooth, then the second shim 10 in sequence,whose shape corresponds to the second tooth, is likewise centered andapplied to the surface. The sequence is repeated for the third shim 10,and so on. Typically, all shims 10 are applied to the teeth in less than30 seconds.

When a shim 10 is to be applied to an misaligned adjacent tooth, thenthe utilizable length of the connecting link 12 is increased byseparating the separable connection. The separable connection of thelink 12 is separated by pulling the shim 10 to be mounted into positionover the misaligned tooth. The shim 10 pulls the connected link 12,which in turn separates the separable connection. In the preferredembodiment, the separable membrane connecting link 10 to shim 10 is tornaway, increasing the utilizable portion of link 12.

If adjacent teeth are misaligned severely enough so that a link 12 willnot stretch between the teeth, despite entirely separating the separableconnection, then link 12 can be cut. Links 12 can also be cut toeliminate sequential shims 10, such as at the positions of missingteeth, or to substitute in shims 10 of different size or shape.

When all shims 10 are adhered to respective teeth surfaces, all links 12are pressed back against the teeth, and between the teeth, so they areout of the way. A mounted spacer 16 is shown in FIG. 2.

Although not necessary for most cases, customizing of shims 10 isperformed after application of spacer 16. However, it may be performedprior, or during application. For example, if an individual shim 10extends beyond the circumference of an unusually shaped tooth on acertain side, then it may be cut to fit. On the other hand, if there isan unusually wide border area of tooth surface extending beyond shim 10,then resin spacer mediums of the art may be added to cover such borderareas.

If spacer 16′ is retained by loop 24, as shown in FIG. 6, then a spacer16′ with a loop 24 is selected, whose shims 10′ are just slightlysmaller than the teeth of model 18, and which have the most effectivecross-sectional shape. Shims 10′ are oriented over the teeth of model18. Loop 24 is stretched around the posterior ends of the posteriorteeth, so that it stretches across the opposite sides of the dentalarch, above the palate. Loop 24 is then pulled down to the palatallevel, out of the way of forming dental tray material, such as byhooking it on loop anchor 26 connected to a rear section of the model.Shims 10 are then centered on each tooth by appropriately stretchingelastic links 12′.

Following the application of any spacer 16, or spacer 16′, on model 18,a non-stick separating medium is applied to spacer 16, or spacer 16′,prior to fabrication of a dental tray. The dental tray stock materialpliability is increased, such as by heating. When sufficient pliabilityis attained, the dental tray stock material is quickly positioned andadapted to cover spacer 16, or spacer 16′, and the teeth, such as overmodel 18. It is preferred that the tray material is made to closelyconform to the shape of spacer 16, or spacer 16′, by applying a strongvacuum to the under-surface of model 18.

After the dental tray material is made less pliable, such as by sittingat room temperature a short time, the formed dental tray with excessflashing material, is loosened and removed from model 18. If spacer 16,or 16′, has become embedded in the dental tray, rather than remainingadhered to model 18, then it must be gently pried free, to avoidbreaking links. Used spacers may be discarded, or sterilized for reuse.The dental tray is completed by trimming away extra dental traymaterial, and assuring that trimmed edges are smooth.

Conclusion, Ramifications, and Scope of Invention

The dental tray spacer of this invention may be quickly adhered to theindividual teeth of most dental arch models, in correct order, and withlittle or no alteration, so that all spacer shapes fit their respectiveteeth.

Accordingly, the reader will see that the dental tray spacer of thisinvention can be used to assure the formation of an adequate reservoirspace between dental trays and the teeth, and that this can be done inminimal time, with little cost, and without requiring a high level ofskill. Most practitioners currently do not provide reservoir spacingunder their treatment agent dental trays during fabrication, primarilydue to the time and cost of techniques of the art. An efficient spacingtechnique, such as this, could translate into saving many hours ofpatient treatment time. For those practitioners that do utilize spacingtechniques of the art, the dental tray spacer can save significant timeand money, and their patients can be shown the visible reservoir spacingin their trays as assurance that they are receiving efficient treatment.

While my above description contains many specificities, these should notbe construed as limitations on the scope of the invention, but rather asan exemplification of some of the presently preferred embodimentsthereof. Many other variations are possible. For example, from anelevational view, spacer 16, or spacer 16′, could be comprised ofsymmetrical, ovoid shaped shims 10, rather than tooth shaped. Forcertain treatments, these would provide adequate reservoir space underthe dental tray. Such symmetrical shims 10 could be supplied in acontinuous chain, from which a spacer 16, of any desired number ofsegments, could be cut.

As a second example, spacer 16 could be applied directly to thepatient's actual teeth, for intraoral dental tray fabricationtechniques, rather than on model 18.

Accordingly, the scope of the invention should be determined, not by theembodiments illustrated, but by the appended claims and their legalequivalents.

1. A preformed dental tray spacer means for shimming moldable dentaltray material a predetermined distance from surfaces of teeth of adental arch, or models thereof, comprising a flat, unitary strip of adeformable material substantially elongate in a longitudinal directionand adaptable for rapid shaping and mounting on said surfaces of teeth,or models thereof, said unitary strip comprising a plurality of toothshim elements connected to each other by means of links, said tooth shimelements having a circumference in the plane of the unitary strip, eachsaid tooth shim element being comformable conformable overlying surfacecontours of a tooth, said links being substantially elongate, a portionof said links being substantially elongate in the longitudinal directionof said unitary strip, said links having a sufficient length such thatadjacent said tooth shim elements are mountable on adjacent saidsurfaces of teeth, wherein said circumference of said tooth shimelements is substantially greater than the width of said links.
 2. Thedental tray spacer means of claim 1, wherein said sufficient length issuch that adjacent said tooth shim elements are mountable on adjacentsaid surfaces of teeth, or models thereof, said surfaces of teeth beingsubstantially misaligned.
 3. The dental tray spacer means of claim 1,wherein a portion of said links are further connected to said spacer bymeans of a separable connection, whereby separating said separableconnection increases utilizable said sufficient length, such thatadjacent said tooth shim elements are mountable on adjacent saidsurfaces of teeth, or models thereof, said surfaces of teeth beingsubstantially misaligned, wherein the connected distance between saidtooth shim elements is increased.
 4. The dental tray spacer means ofclaim 1, wherein each of said tooth shim elements have distinctcircumferential shapes, and said teeth have distinct circumferentialshapes, and said circumferential shapes of said tooth shim elementssubstantially resemble said circumferential shapes of respective saidteeth upon which each of said tooth shim elements would be mounted. 5.The dental tray spacer means of claim 1, wherein said tooth shimelements have a surface for mounting against said surfaces of teeth, ormodels thereof, said surface of said tooth shim element being coatedwith an adhesive.
 6. A preformed dental tray spacer means for shimmingmoldable dental tray material a predetermined distance from surfaces ofteeth of a dental arch, or models thereof, comprising a flat, unitarystrip of a deformable material substantially elongate in a longitudinaldirection and adaptable for rapid shaping and mounting on said surfacesof teeth, or models thereof, said unitary strip comprising a pluralityof tooth shim elements connected to each other by means of links, saidtooth shim elements having a circumference in the plane of the unitarystrip, each of said tooth shim element being comformable conformableoverlying surface contours of a tooth, said links being substantiallyelongate, a portion of said links being substantially elongate in thelongitudinal direction of said unitary strip, said links having asufficient length such that adjacent said tooth shim elements aremountable on adjacent said surfaces of teeth, wherein said circumferenceof said tooth shim elements is substantially greater than the width ofsaid links, wherein a portion of said links are further connected tosaid spacer by means of a separable connection, whereby separating saidseparable connection increases utilizable said sufficient length, suchthat adjacent said tooth shim elements are mountable on adjacent saidsurfaces of teeth, or models thereof, said surface of teeth beingsubstantially misaligned, wherein the connected distance between saidtooth shim elements is increased.
 7. The dental tray spacer means ofclaim 6, wherein said separable connection is a thin membrane.
 8. Thedental tray spacer means of claim 6, wherein said separable connectionconnects said links to said tooth shim elements.
 9. The dental trayspacer means of claim 6, wherein each of said tooth shim elements havedistinct circumferential shapes, and said teeth have distinctcircumferential shapes, and said circumferential shapes of said toothshim elements substantially resemble said circumferential shapes ofrespective said teeth upon which each of said tooth shim elements wouldbe mounted.
 10. The dental tray spacer means of claim 6, wherein saidtooth shim elements have a surface for mounting against said surfaces ofteeth, or models thereof, said surface of said tooth shim elements beingcoated with an adhesive.
 11. A preformed dental tray spacer means forshimming dental tray material a predetermined distance from preferredsurfaces of dental arch model teeth, comprising a plurality of toothshim elements connected by links of variable length, said linkscomprised of elastic material, wherein one said link is of sufficientlength to stretchingly encompass the circumference of a dental model,such that said tooth shim elements are retainably pulled against saidsurfaces of said teeth; wherein remaining said links stretchsufficiently to permit rapid positioning of said shims against saidsurfaces of said teeth.
 12. The dental tray spacer means of claim 11,wherein each of said tooth shim elements have distinct circumferentialshapes, and said teeth have distinct circumferential shapes, and saidcircumferential shapes of said tooth shim elements substantiallyresemble said circumferential shapes of respective said teeth upon whicheach of said tooth shim elements would be mounted.
 13. The dental trayspacer means of claim 11, wherein said tooth shim elements have asurface for mounting against said teeth, said surface being coated withan adhesive.
 14. A method of connecting a dental tray spacer to a dentalarch model comprising the acts of: providing a loop that is connected torightmost and leftmost portions of the spacer; and connecting the loopto a rear section of the model in order to retain the spacer in place.15. A method of connecting a dental tray spacer to a dental arch modelaccording to claim 14 wherein the act of connecting the loop to a rearsection of the model includes the act of stretching the loop.
 16. Amethod of connecting a dental tray spacer to a dental arch modelaccording to claim 15 wherein the act of stretching the loop includesthe act of stretching the loop around the posterior ends of theposterior teeth of the model.
 17. A method of connecting a dental trayspacer to a dental arch model according to claim 14 and including theact of pulling the loop toward a palatal level.
 18. A method ofconnecting a dental tray spacer to a dental arch model according toclaim 14 and including the act of applying a non-stick separating mediumto the spacer.
 19. A method of connecting a dental tray spacer to adental arch model according to claim 14 and including the act of placingthe spacer across a multiple number of teeth of the model.
 20. A methodof connecting a dental tray spacer to a dental arch model according toclaim 14 wherein the act of connecting the loop to a rear section of themodel includes the act of hooking the loop to an anchor.
 21. A method ofconnecting a dental tray spacer to a dental arch model according toclaim 14 and including the act of retaining the dental tray spacer tothe dental arch model with adhesion.
 22. A method of making a dentaltray comprising the acts of: providing an elongated spacer; placing thespacer over facial surfaces of teeth of a dental arch model such thatthe spacer is generally centered with respect to the center of thedental arch in a mesial-distal direction such that the longitudinal axisof the spacer extends along the length of the arch and such that thespacer extends over more than one tooth of the dental arch model; andforming a sheet of elastomeric tray material over the spacer and thedental arch model to create a dental tray.
 23. A method of making adental tray according to claim 22 and including the act of providing anadhesive surface on the spacer for adhesion to the dental arch model.24. A method of making a dental tray according to claim 23 and includingthe act of removing a backing from the adhesive surface prior tomounting the spacer on the dental arch model.
 25. A method of making adental tray according to claim 22 wherein the act of placing the spaceron the dental arch model includes the act of placing the spacer acrossthe tips of papilla of model gingiva between adjacent teeth of thedental arch model.
 26. A method of making a dental tray according toclaim 22 and including the act of pressing the spacer into the embrasurecrevice between the teeth.
 27. A method of making a dental trayaccording to claim 22 and including the act of freeing the spacer fromthe tray after the tray is formed.
 28. A method of making a dental traycomprising the acts of: providing an elongated spacer; placing thespacer over facial surfaces of teeth of a dental arch model such thatthe spacer is generally centered with respect to the center of thedental arch in a mesial-distal direction; applying a non-stickseparating medium to the spacer; and forming a sheet of elastomeric traymaterial over the spacer and the dental arch model to create a dentaltray.
 29. A method of making a dental tray comprising the acts of:providing an elongated spacer; providing a loop that is connected torightmost and leftmost portions of the spacer; placing the spacer overfacial surfaces of teeth of a dental arch model such that the spacer isgenerally centered with respect to the center of the dental arch in amesial-distal direction; connecting the loop to a rear section of themodel in order to retain the spacer in place; and forming a sheet ofelastomeric tray material over the spacer and the dental arch model tocreate a dental tray.
 30. A preformed dental tray spacer for shimmingmoldable dental tray material a predetermined distance away fromsurfaces of teeth of a dental arch or models thereof comprising aunitary, elongated strip of material having an adhesive surface, and abacking removably connected to the adhesive surface, wherein the spacerhas edges that are tapered to an acute angle.
 31. A preformed dentaltray spacer according to claim 30 wherein the adhesive surface issufficiently pliable to conform closely to curved, irregular surfaces ofteeth of tissue.
 32. A preformed dental tray spacer for shimmingmoldable dental tray material a predetermined distance away fromsurfaces of a dental arch or models thereof comprising a unitary,elongated strip of material having an adhesive surface, and a backingremovably connected to the adhesive surface, wherein the spacer has arightmost portion and a leftmost portion, and wherein the spacerincludes a loop connected to the rightmost portion and the leftmostportion.
 33. A preformed dental tray spacer according to claim 32wherein the loop is stretchable.
 34. An assembly comprising: a dentalarch model; a dental tray spacer for shimming moldable dental traymaterial a predetermined distance away from surfaces of teeth of themodel, the spacer comprising a unitary, elongated strip of materialhaving an adhesive surface in contact with the model and extending alongthe length of the arch, wherein the spacer has edges that are tapered toan acute angle; and a non-stick separating medium applied to the spacerfor contact with the tray material.